UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003019 |
|---|---|
| Receipt number | R000003507 |
| Scientific Title | Evaluation of plasma coagulation factors as additional parameter for indication of the emergency operation for type A acute aortic dissection |
| Date of disclosure of the study information | 2010/01/18 |
| Last modified on | 2015/02/08 18:46:05 |
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Basic information
Public title
Evaluation of plasma coagulation factors as additional parameter for indication of the emergency operation for type A acute aortic dissection
Acronym
Evaluation of prognostic significance of coagulation factor in acute aortic dissection(CFAAD study)
Scientific Title
Evaluation of plasma coagulation factors as additional parameter for indication of the emergency operation for type A acute aortic dissection
Scientific Title:Acronym
Evaluation of prognostic significance of coagulation factor in acute aortic dissection(CFAAD study)
Region
| Japan |
Condition
Condition
Acute aortic dissection(Stanford type A)
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is undertaken to evaluate whether blood coagulation factor testing is a good indication of emergency surgery or not in the type A acute aortic dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
in-hospital mortality
Key secondary outcomes
The occurrence of any of following complication
1 Cardiac tamponade
2 Shock due to the rupture of aorta
3 central nerve disorder
4 acute coronary syndrome
5 Severe lower limbs ischemia or necrosis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who are diagnosed as type A acute aortic dissection
Key exclusion criteria
non
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Kei |
Organization
National Hospital Organization Kumamoto Medical Center
Division name
Cardiovascular surgery
Zip code
Address
1-5, Ninomaru, Kumamoto 860-0008, Japan
TEL
096-353-6501
j-kei@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jyun-ichi Kei |
Organization
National Hospital Organization Kumamoto Medical Center
Division name
Cardiovascular surgery
Zip code
Address
1-5, Ninomaru, Kumamoto 860-0008, Japan
TEL
096-353-6501
Homepage URL
j-kei@za2.so-net.ne.jp
Sponsor or person
Institute
Natonal Hospital Organization Kumamoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Natonal Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
00国立病院機構熊本医療センター（熊本県）
01国立病院機構大阪医療センター（大阪府）
02国立病院機構鹿児島医療センター（鹿児島県）
03国立病院機構九州医療センター（福岡県）
04国立病院機構嬉野医療センター（佐賀県）
05国立病院機構長崎医療センター（長崎県）
06国立病院機構仙台医療センター（宮城県）
07国立病院機構静岡医療センター(静岡県）
08国立病院機構呉医療センター（山口県）
09国立病院機構岩国医療センター（広島県）
10国立病院機構北海道がんセンター（北海道）
11国立病院機構岡山医療センター(岡山県）
12国立病院機構水戸医療センター（茨城県）
13国立病院機構長良医療センター(岐阜県）
14国立病院機構災害医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
http://www.hosp.go.jp/~knh/03iryokankei/rinsyokenkyu/nhonetwork.html
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
I,study design : multicenter prospective cohort study
II,observation valuables at first hospital visit
1,Age, Sex
2,Duration from onset to the hospital visit
3,Extension of false lumen
4,Status of the false lumen
5,Maximum diameter of the ascending aorta
6,Diameter of true and false lumen at the same level
7,Pericardial effusion volume
8,Cardiac tamponade
9,Disturbance of central nerve system
10,Acute coronary syndrome
11,Acute lower limbs ischemia
12,Status of urgency
Laboratory data
13,Prothrombin time - International normalized raio
14,Activated partial thromboplastin time
15,fibrin/fibrinogen degradation products
16,D-dimer
17,Plasminogen activity
18,Antithrombine III
19,Alpha 2 plasmin inhibitor
20,Fibrinogen
21,Hemoglobine
22,EBC counts
23,Platelet counts
24,Aspartate aminotransferase
25,Aalanine aminotransferase
26,Creatinine
27,Creatine kinase
28,C-reactive protein
When urgent or immediate surgery is performed,
29,Duration from hospital visit to surgery
30,Range of replaced aorta
31,Concomitant operation
32,Blood transfusion volume
33,Operation time
34,Extra-corporeal circulation time
35,Circulatory arrest time
36,Aortic clamp time
37,Selective cerebral perfusion time
III, Statistical analysis
1) We divide it into two groups according to surgical and non-surgical treatment.
2) Among each group observation variables demonstrating significant influence on the incidences of the primary or secondary outcomes will be identified using chi-square tests and logistic regression analysis. Among these significant variables, independent factors which influence on primary or secondary outcomes will be identified using multiple logistic regression analysis.
3)We will design a formula to predict early mortality and morbidity among each surgical and non-surgical and both group using multiple logistic regression analysis. and we will evaluate the fomula as the parameter of early surgical indication for type A acute aort
Management information
Registered date
| 2010 | Year | 01 | Month | 12 | Day |
Last modified on
| 2015 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003507
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
